Regulations

35 Results

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

FDA Focus̶ Product Design and Post Approval Changes

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

SGS-LSS

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Article on Viral Clearance for Biopharmaceuticals

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals.  These studies are a key component...

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Transforming Clinical Development

Transforming Clinical Development

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...